Definition: An Oral Lubricant To Be Used Adjacent To Hard And Soft Tissue And The Lips To Prevent Adherence Of Dental Cement; Placement Of A Rubber Dam; And To Prevent The Lips From Drying And Cracking During Dental Procedures.
| Device Type ID | 1392 |
| Device Name | Oral Lubricant |
| Physical State | Viscous Liquid Or Gel |
| Technical Method | Direct Application |
| Target Area | Oral Hard And Soft Tissue |
| Regulation Description | Patient Lubricant. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6375 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ONK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1392 |
| Device | Oral Lubricant |
| Product Code | ONK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Patient Lubricant. |
| CFR Regulation Number | 880.6375 [🔎] |